BIOTHERM— 510(k) K833839
Substantially EquivalentTrileen, Inc.
FDA 510(k) clearance K833839 for BIOTHERM, Substantially Equivalent on 1983-12-27. Applicant: Trileen, Inc.. Device class: 2.
Clearance details
- Applicant
- Trileen, Inc.
- Product code
- Code ILJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5100
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
Recent devices under product code ILJ
view allMore clearances from Trileen, Inc.
view allAdverse events under product code ILJ
product code ILJ- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.